Estimating the Malaria Prevention Impact of New Nets: Observational Analyses to Evaluate the Evidence Generated During Piloted New Net Distributions in Rwanda

NCT04230161 | Completed

• 1 other identifier: 1409734-2
• Study Type: observational
• Target: 3,502
• Locations: 1 country
• Sites: 1

Brief Summary

The use of insecticide-treated bed nets (ITNs) has contributed to the substantial reduction in malaria cases and deaths. This progress is threatened by increasing resistance in mosquito populations to commonly used insecticides. Newly developed, next-generation ITNs using two insecticides or an insecticide synergist and an insecticide are effective against resistant mosquitoes, but large-scale uptake of these nets has been slow due to higher costs and lack of enough evidence to support broad policy recommendations. This observational study will occur alongside a pilot distribution of next-generation ITNs and collect data over three years on their entomological and epidemiological impact as well as anthropological factors that influence their uptake and use. Enhanced data collection will occur in three districts: one district that will receive Interceptor G2 ® ITN (BASF) and two comparator districts, one that will receive standard pyrethroid-only ITNs and one that will receive standard pyrethroid-only ITNs and indoor residual spraying (IRS). Data will be collected on malaria vector bionomics, disease epidemiology, and human behaviors in order to help better demonstrate the public health value of next-generation ITNs and to support donors, policymakers, and National Malaria Control Programs in their ITN decision-making and planning processes.

Conditions

Malaria

Keywords

Long-lasting insecticidal net; LLIN; Insecticide treated net; ITN; Malaria; Epidemiology; Anthropology; Durability; Cost-effectiveness

Outcome Measures

Primary Outcomes (1)

• Cumulative malaria incidence

  Malaria incidence measured through passive case detection at health facilities in each district. This measure accounts for symptomatic cases self-reporting to the formal health system for care.

  November 2019 to December 2022, monthly

Secondary Outcomes (6)

• Vector species composition

  December 2019 to December 2022, monthly

• Species-specific population densities

  December 2019 to December 2022, monthly

• Biting behaviors

  December 2019 to December 2022, monthly

• Estimated entomological inoculation rates

  December 2019 to December 2022, monthly

• Insecticide resistance profile

  December 2019 to December 2022, monthly

Study Arms (3)

Standard LLIN

This group receives Yahe LN ITNs during the mass distribution campaign.

Other: Standard long-lasting insecticidal net

Chlorfenapyr ITN

This group receives Interceptor G2 ITNs during the mass distribution campaign.

Other: Chlorfenapyr insecticide treated net

Standard LLIN and IRS

This group receives Yahe LN ITNs during the mass distribution campaign and IRS.

Other: Standard long-lasting insecticidal net; Other: Indoor residual spraying

Interventions

Standard long-lasting insecticidal net OTHER

Yahe LN (Yamei Industry) contains a pyrethroid insecticide.

Also known as: Yahe LN

Standard LLIN; Standard LLIN and IRS

Chlorfenapyr insecticide treated net OTHER

Interceptor G2® (BASF) is an ITN containing two active ingredients: Alpha-cypermethrin, a pyrethroid insecticide, and chlorfenapyr, a pyrrole insecticide.

Also known as: Interceptor G2®

Chlorfenapyr ITN

Indoor residual spraying OTHER

Fludora Fusion (Bayer Vector Control) is a spray containing two active ingredients: clothianidin, a neonicotinoid insecticide, and deltamethrin, a pyrethroid insecticide.

Also known as: Fludora Fusion

Standard LLIN and IRS

Eligibility Criteria

• Age: 6 Months+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Households selected for enrollment in the cross-sectional survey will be randomly selected from each of the three study districts: Ruhango, Nyamagabe, and Karongi. All members of the selected households will be asked to participate in the malaria biomarker survey to test for malaria using an RDT. The villages selected for anthropological surveillance will be the same as those used for entomological surveillance. Passive case detection data will include all malaria tests recorded in all health facilities in the three study districts.

You may qualify if:

• Passive data collection: all suspected malaria cases (fevers) that self-present to the national health system and are counted in the district health surveillance systems.
• Cross sectional survey: Households in the district.
• Residents of the household visited.
• Questionnaire: any adult member of the household .
• Malaria screening: all members aged 6 months or older from the above consenting household.
• Individuals of box sexes, not belonging to vulnerable categories (those with cognitive impairment or other person for whom full and open consent cannot be guaranteed) (Key informant interviews, focus group discussions, and participant observations).
• Individuals 18 years old and above (Key informant interviews, focus group discussions, and observations).
• Individuals of both sexes regardless of age (observations).

You may not qualify if:

• District non-residents.
• Malaria screening: history of recent (within one month) malaria infection or treatment with anti-malarial medication (cross-sectional).
• Parents or guardians who have not yet reached age of consent (18 years) and their children will not be included in study activities requiring consent.
• Individuals belonging to vulnerable categories (key informant interviews, focus group discussions, observations).
• Individuals unwilling and/or unable of giving consent (key informant interviews, focus group discussions, observations).
• Individuals below age of consent (20 years) (key informant interviews, focus group discussions, observations).
• Heads of households unwilling and/or unable of giving consent (observations).
• Individuals who do not wish to be included in observations will be excluded (observations).

Sponsors & Collaborators

• PATH: lead
• Rwanda Biomedical Centre: collaborator
• University of Rwanda: collaborator
• Liverpool School of Tropical Medicine: collaborator

Study Sites (1)

Rwanda Biomedical Centre

Kigali, Rwanda

Location

Related Publications (14)

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Related Links

• Bernard, HR. Research Methods in Anthropology: Qualitative and Quantitative Approaches. 4th
• Ben-Shlomo Y, Brookes S, Hickman M. Lecture Notes: Epidemiology, Evidence-based Medicine and Public Health.
• Malaria and Other Parasitic Diseases Division (MOPDD) of the Rwanda Biomedical Center Ministry of Health. National Guidelines for the Treatment of Malaria in Rwanda.
• Malaria and Other Parasitic Diseases Division (MOPDD) of the Rwanda Biomedical Center Ministry of Health and ICF. Rwanda Malaria Indicator Survey (RMIS) 2017
• National Institute of Statistics of Rwanda (NISR), Ministry of Health (MOH) \[Rwanda\], and ICF International. Rwanda Demographic and Health Survey 2014 - 15
• The US President's Malaria Initiative (PMI) Africa Indoor Residual Spraying (AIRS) Project. The PMI AIRS Project Semi-Annual Report: October 1, 2016 - March 31, 2017.
• The US President's Malaria Initiative (PMI). Rwanda: Malaria Operational Plan FY 2019.
• United Nations (UN). Outreach Programme on the Rwanda Genoicde and the United Nations.
• Malkki, L., 1995. Purity and Exile: Violence, Memory, and National Cosmology.
• Lévi-Strauss, C., 1969. The elementary structures of kinship (No. 340).

MeSH Terms

Conditions

Malaria

Condition Hierarchy (Ancestors)

Protozoan Infections; Parasitic Diseases; Infections; Mosquito-Borne Diseases; Vector Borne Diseases

Study Officials

• Joseph Wagman, PhD

  PATH

  PRINCIPAL INVESTIGATOR

• Aimable Mbituyumuremyi, MD

  Rwanda Biomedical Centre

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 14, 2020
• First Posted: January 18, 2020
• Study Start: February 24, 2020
• Primary Completion: November 18, 2022
• Study Completion: November 18, 2022
• Last Updated: January 25, 2023

Record last verified: 2023-01

Data Sharing

• IPD Sharing: Will not share

Locations

RW (1)